Job summary
To lead and be accountable for all technical aspects of the preparation of medicines under MHRA "Specials" Licence at the CIVAS@IP5 unit.
To be the Production Lead for Technical Services and comply with the responsibilities named on the MHRA licence as stated in the latest version of 'Rules and guidance for the Pharmaceutical Manufacturers and Distributors' for activities carried out under 'Manufacturers Special Licence'.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
Main duties of the job
To lead and be accountable for all technical aspects of the preparation of medicines under MHRA "Specials" Licence at the CIVAS@IP5 unit.
To be the Production Lead for Technical Services and comply with the responsibilities named on the MHRA licence as stated in the latest version of 'Rules and guidance for the Pharmaceutical Manufacturers and Distributors' for activities carried out under 'Manufacturers Special Licence'.
Along with the with Head of Technical Services - CIVAS@IP5, to be a formal contact for the MHRA inspectors and auditors discussing issues raised and negotiating the contents of the final report.
To assist the Quality Assurance team in identifying, evaluating and developing new Aseptic services, analysing data, evaluating need, assessing local and national initiatives.
Along with the with Head of Technical Services - CIVAS@IP5, take a lead role in planning, designing, negotiating, commissioning, and operating new aseptic facilities or upgrades to existing facilities.
To be accountable for the service delivery and operational management of the Technical Services at the CIVA@IP5 unit in accordance with departmental strategic and business plans.
To be line manager for the Production Manager.
To be responsible for ensuring all technical staff are trained and adequately assessed through effective training programmes in line with local regional and national guidance.
About us
At NHS Wales Shared Services Partnership we expect everyone to embrace our values of Listening and Learning, Working Together, Taking Responsibility and Innovating.
Our organisation encourages an agile working approach and we pride ourselves on being a learning organisation motivated by continuous improvement.
We are committed to creating an inclusive workplace that values equality, diversity and inclusion, focussing on the wellbeing and belonging of our people.
Excellent customer service is something we strive for, for both our internal and external customers.
Offering a comprehensive benefits package, there is something for everyone. To find out more about working for us, the benefits we offer and guidance on the application process please visit https://nwssp.nhs.wales/working-for-us/
NWSSP work in an agile way where possible, all posts will have a contractual base but as part of agile ways of working that may mean working from home and other locations. We also look at how we balance flexibility with community, and how to manage opportunities to learn from each other.
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
To possess and maintain specialist knowledge of Management with ILM Level 5 / Diploma level or equivalent qualification.
To plan, implement, maintain, and evaluate operational activities including staff, resources, activity, processes, and information.
To identify, evaluate and implement new services, and improvements to existing services, when required in conjunction with the with Head of Technical Services CIVAS@IP5 and senior leadership team in CIVAS@IP5.
To promote good working relationships between all grades of staff.
To motivate and inspire the Production Team, including developmental leadership to the Senior Pharmacy Technicians
To continually assess the service provided and to make improvements to ensure best practice is adopted at all times.
To manage the overall workload in accordance with the Capacity Plan.
To ensure staff rotas reflect an appropriate skill mix for the allocated tasks and are an effective use of staff time. When normal services cannot be provided, to identify need and negotiate with other healthcare professionals inside and outside the department to ensure resources are appropriately allocated in a safe and effective manner.
On a day to day basis communicate sometimes difficult and potentially contentious information back to the appropriate healthcare professionals.
To ensure effective, up to date standard operating procedures (SOPs) and processes are available within Technical Services, and that the SOPs comply with national, regional and local guidance.
This will involve writing, authorising, implementing, and reviewing SOPs on an ongoing basis.
To be responsible for ensuring all equipment is validated and functioning correctly. To be responsible for ensuring all plant and equipment planned preventative and corrective maintenance is carried out.
To manage the environmental monitoring processes in line with current guidance and to ensure correct action is taken in the event of a deviation. To liaise with the Quality Assurance team where appropriate to resolve any validation or monitoring issues.
To regularly review the levels of technical and administrative staffing and ensure the appropriate skills mix is maintained for production and wholesale dealing activities.
To oversee management of production and wholesale dealing services provided by the CIVAS@IP5 unit Aseptic Services Unit.
To contribute to the management of effective resolution of customer complaints, product defects and recalls in adherence with Departmental, Trust, National and regional guidance.
To work within the organisational policies and procedures and be responsible for all aspects of recruitment and retention of technical and support staff.
To work within the organisational policies and procedures and be responsible for ensuring the management and monitoring of technical and administrative staff attendance, sickness and other absence, annual leave, study leave and career development.
To work within the organisational policies and procedures and take part in proceedings that may be required in disciplinary, grievance, fair treatment cases.
To liaise with healthcare professionals and commercial suppliers externally to manage medicines supply.
To be responsible for co-ordinating the recruitment of all technical and administrative staff.
To be responsible for ensuring that the Site Master File is updated and maintained. To analyse data, write reports and present findings for publication and internal use when required.
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
To possess and maintain specialist knowledge of Management with ILM Level 5 / Diploma level or equivalent qualification.
To plan, implement, maintain, and evaluate operational activities including staff, resources, activity, processes, and information.
To identify, evaluate and implement new services, and improvements to existing services, when required in conjunction with the with Head of Technical Services CIVAS@IP5 and senior leadership team in CIVAS@IP5.
To promote good working relationships between all grades of staff.
To motivate and inspire the Production Team, including developmental leadership to the Senior Pharmacy Technicians
To continually assess the service provided and to make improvements to ensure best practice is adopted at all times.
To manage the overall workload in accordance with the Capacity Plan.
To ensure staff rotas reflect an appropriate skill mix for the allocated tasks and are an effective use of staff time. When normal services cannot be provided, to identify need and negotiate with other healthcare professionals inside and outside the department to ensure resources are appropriately allocated in a safe and effective manner.
On a day to day basis communicate sometimes difficult and potentially contentious information back to the appropriate healthcare professionals.
To ensure effective, up to date standard operating procedures (SOPs) and processes are available within Technical Services, and that the SOPs comply with national, regional and local guidance.
This will involve writing, authorising, implementing, and reviewing SOPs on an ongoing basis.
To be responsible for ensuring all equipment is validated and functioning correctly. To be responsible for ensuring all plant and equipment planned preventative and corrective maintenance is carried out.
To manage the environmental monitoring processes in line with current guidance and to ensure correct action is taken in the event of a deviation. To liaise with the Quality Assurance team where appropriate to resolve any validation or monitoring issues.
To regularly review the levels of technical and administrative staffing and ensure the appropriate skills mix is maintained for production and wholesale dealing activities.
To oversee management of production and wholesale dealing services provided by the CIVAS@IP5 unit Aseptic Services Unit.
To contribute to the management of effective resolution of customer complaints, product defects and recalls in adherence with Departmental, Trust, National and regional guidance.
To work within the organisational policies and procedures and be responsible for all aspects of recruitment and retention of technical and support staff.
To work within the organisational policies and procedures and be responsible for ensuring the management and monitoring of technical and administrative staff attendance, sickness and other absence, annual leave, study leave and career development.
To work within the organisational policies and procedures and take part in proceedings that may be required in disciplinary, grievance, fair treatment cases.
To liaise with healthcare professionals and commercial suppliers externally to manage medicines supply.
To be responsible for co-ordinating the recruitment of all technical and administrative staff.
To be responsible for ensuring that the Site Master File is updated and maintained. To analyse data, write reports and present findings for publication and internal use when required.
Person Specification
Experience
Essential
- Worked at MHRA Licenced Facility
- Worked as production lead or deputy
Qualifications
Essential
- PTQA to Masters or Diploma Level
Person Specification
Experience
Essential
- Worked at MHRA Licenced Facility
- Worked as production lead or deputy
Qualifications
Essential
- PTQA to Masters or Diploma Level
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
